LOCAL CONTACT INFORMATION/ HIPAA FOR INFORMED CONSENT DOCUMENT
Provide specific information about who is conducting the study in San Antonio, Texas, and give the names and telephone
numbers for the PI and a Sub-I, explaining that they should be contacted for questions or problems related to the study.
Include instruction on how to contact them after hours.
After the paragraph giving the External IRB information, insert the following:
The University of Texas Health Science Center at San Antonio is the local Institutional Review Board committee that
reviews research on human subjects (Institutional Review Board) and can also answer any questions about your rights as
a research subject, and take any concerns, comments or complaints you may wish to offer. You can contact the IRB by
calling 210-567-8250, or by mail to IRB, UTHSCSA, Mail Code 7830, 7703 Floyd Curl Drive, San Antonio, TX 78229-3900.
Include all sections that are not part of the informed consent document:
Confidentiality
Information we learn about you in this study will be handled in a confidential manner, within the limits of the law. If we
publish the results of the study in a scientific journal or book, we will not identify you. The Institutional Review Board
and other groups, such as the Food and Drug Administration (FDA) that have the responsibility of monitoring research
may want to see study records which identify you as a subject in this study.
Information about how this study will use your Protected Health Information (PHI)
Taking part in the study will require the researchers to have and to use private information about you and your health.
It will also be necessary for the researchers to permit other groups to see records that contain information about you
and your health. The federal privacy regulations only permit the researchers to collect, use or share your identifiable
health information if you give them your permission to do so.
Research policies require that private information about you be protected and this is especially true for your health
information. However, the law sometimes allows or requires others to see your information. The information given
below describes how your privacy and the confidentiality of your research records will be protected in this study.
What is Protected Health Information (PHI)?
Protected Health Information is information about a person’s health that includes information that would make it
possible to figure out who the person is. According to the law, you have the right to decide who can see your protected
health information. If you choose to take part in this research study, you will be giving your permission to the
investigators and the research study staff (individuals carrying out the study) to see and use your health information for
the study. In carrying out this research, the health information we will see and use about you will include: [modify the
below information as appropriate for your study]
 your medical history and blood work,
 pathology, imaging and radiology reports and results of medical tests,
 information from interviews or from questionnaires,
 demographic information like your age, marital status, the type of work you do and the years of education you
have completed.
We will get this information from the study procedures that will be done, by asking you, asking your doctor, and/or by
looking at your chart at [specify the institutions where the study is being done, such as University of Texas Health
Science Center at San Antonio, University Health System (UHS).]
How will your PHI be shared?
Because it is research, we will be unable keep your PHI completely confidential. We may share your health information
with people and groups involved in conducting and overseeing this research study including:
 The sponsor of the study, [Insert names of the sponsor and other groups involved in the study].
 [If Applicable, INSERT] Representatives of [name of company] the company that makes the study drug/device;
 [If the study involves a drug or device regulated by the FDA regardless of whether test article is already
approved, INSERT]The Food and Drug Administration (FDA) and other U.S. and international governmental
regulatory agencies involved in overseeing drug or device research;
 [If the study has a DSMB/DSMC, INSERT]The committee that checks the study data on an ongoing basis, to
determine if the study should be stopped for any reason;
 The members of the local research team;
 The Institutional Review Board and the Compliance Office of the University of Texas Health Science Center at
San Antonio, and other groups that oversee how research studies are carried out; and
 The Research office at [specify the institutions where the study is being done, such as University Health System
(UHS).]
Parts of your PHI may be photocopied and sent to a sponsor or data coordinating center, as appropriate, or it may be
transmitted electronically, such as by e-mail or fax.
Some groups receiving your PHI may not be obligated to keep it private. They may pass information on to other groups
or individuals not named here.
If you choose not to let these groups collect, use and share your health information as explained above, you will not be
able to participate in this research study.
How will your PHI be protected?
In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health
information. Initials and numbers will be used on any photocopies of your study records, and other study materials
containing health information that are sent outside of [specify the institutions where the study is being done, such as
University of Texas Health Science Center at San Antonio, University Health System (UHS).] for review or testing. If the
results of this study are reported in medical journals or at meetings, you will not be identified.
Do you have to allow the use of your health information?
You do not have to allow (authorize) the researchers and other groups to see and share your health information. If you
choose not to let the researchers and other groups use your health information, there will be no penalties, but you will
not be allowed to participate in the study.
After you enroll in this study, you may ask the researchers to stop using your health information at any time. However,
you need to say this in writing and send your letter to [Insert name and complete mailing address of the person to
whom a request to revoke must be sent]. If you tell the researchers to stop using your health information, your
participation in the study will end and the study staff will stop collecting new health information from you and about you
for this study. However, the study staff will continue to use the health information collected up to the time they receive
your letter asking them to stop.
Can you ask to see the PHI that is collected about you for this study?
The federal rules say that you can see the health information that we collect about you and use in this study. Contact
the study staff if you have a need to review your PHI collected for this study. [Explain any limitations that might affect
the subjects’ access to their PHI, for example: You will only have access to your PHI until [insert date or event]. OR, if the
nature of the study makes it necessary or preferable to temporarily suspend access, explain this by adding: Because of
the type of research, you can only access your PHI when the study is done. At that time, you have the right to see and
copy the medical information we collect about you during the study, for as long as that information is kept by the study
staff and other groups involved.
How long will your PHI be used?
Choose either the authorization to use PHI expires at the end of the study or state the specific date when PHI will no
longer be used. This element is required by HIPAA regulations to be in an authorization.
End of the study
By signing this form, you agree to let us use and disclose your health information for purposes of the study until the end
of the study. This permission to use your personal health information expires when the research ends and all required
study monitoring is over.
OR, on a specific date
By signing this form, you agree to let us use and disclose your health information for purposes of the study until (insert a
specific date). This permission to use your personal health information expires on the date noted above.